Manager, Quality Engineering

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

The Manager, Quality Engineering will oversee Quality Engineering and Operations for Intuitive’ s manufacturing facility for Advanced Tissue Models (ATM) in the Chapel Hill, NC location and will be responsible for product quality and compliance to quality system procedures and regulatory requirements. Primary functional responsibilities include quality engineering, quality compliance, quality assurance, product release (DHR), and continuous improvement to ensure adherence to company quality standards. The Quality Manager will be responsible for measuring and improving the site’s quality performance and will directly support all internal and external audits for the site. This role will work directly with plant leadership to align on goals and objectives. The Quality Manager will manage the team of Quality Engineers and Quality technicians supporting the site, evaluating their performance, and further helping them learn and grow.

Essential Job Duties

• Serve as quality representative for the Advanced Tissue models, Chapel Hill facility.
• Develop and execute short-term and long-term quality strategies necessary to support operations and growth goals.
• Lead group of Quality Engineers & Technicians and support them with their goals, and day-to-day responsibilities.
• Liaison with other Quality functions representatives at other Intuitive locations and with other company functions as it applies.
• Foster Six Sigma and continuous improvement culture in the organization.
• Interface with internal customers to provide status of open issues and drive those items to closure.
• Represent the Quality function in projects of medium to high complexity, product escalations, CAPA's, external and internal audits.
• Lead metrics and guidelines to functions to assist in trending and improving quality.
• Assure all operations performed in accordance with quality management system and procedures.
• Assess issues and escalates based on criticality.
• Support New Product Introduction initiatives by assessing Quality Engineering resources needed and allocation.
• Support for deep technical failure analysis and analysis of challenging quality issues

Qualifications

Preferred Skills and Experience

• Education: Minimum BS in Engineering degree (master’s degree is preferred) or equivalent experience.
• Lean training or Six Sigma certification highly desirable .
• Minimum of 6 years’ experience in quality supporting manufacturing operations; experience in medical device preferred.
• Minimum of 2 years' experience in people management.
• Proven ability to build and manage teams and to project-manage cross-functionally.
• Strong analytic skills as proven by track record for analyzing and fixing complex problems in products and processes.
• Solid understanding of ISO9001 standard.
• Training or commensurate experience in the science of quality.
• Proven ability to lead and motivate across functional boundaries.
• Proven ability to manage through conflicting requirements and make difficult trade-offs when resources are scarce.
• A passion for doing the vital thing, efficiently and well.
• Excellent judgment in the presence of competing priorities and incomp